Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K041094 |
Device Name |
HSG CATHETER SET |
Applicant |
BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
DENIS DORSEY |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/27/2004 |
Decision Date | 06/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|